| Protecting
the Public Health: FDA Pursues an Aggressive Enforcement Strategy |
June 30, 2003
|
| Summary
Information for - Philips Series 50 XMO Fetal/Maternal Monitor (Model
M1350C) with Integrated Fetal Oxygen Saturation Monitoring - P020028 |
June 25, 2003
|
| Public
Workshop: SARS Diagnostics: Scientific and Regulatory Challenges - July
14, 2003 |
June 24, 2003
|
| Consumer
Information on: Osteonics(r) ABC System and Trident(tm) System |
June 24, 2003
|
| Summary
Information for - ALERT(r) System (ALERT(r) Catheter, ALERT(r) Interface
Cable, and ALERT(r) Companion(tm) with Software Version 1.08) - P990069 |
June 24, 2003
|
| Summary
Information for - IMMULITE(r) HBsAg, IMMULITE(r) 2000HBsAg and IMMULITE(r)
HBsAg Confirmatory Kit - P010050 |
June 24, 2003
|
| Summary
Information for - IMMULITE(r) Anti-HBc IgM and IMMULITE(r) 2000 Anti-HBc
IgM - P010053 |
June 24, 2003
|
| Summary
Information for - IMMULITE(r) Anti-HBc and IMMULITE(r) 2000 Anti-HBc - |
June 24, 2003
|
| Summary
Information for - IMMULITE(r) Anti-HBs and IMMULITE(r) 2000 Anti-HBs -
P010052 |
June 24, 2003
|
| FDA
Talk Paper: FDA Announces Pilot Program to Post Warning Letter Responses |
June 23, 2003
|
| Transcripts
from the 6/9 - 6/10 /03 Obstetrics and Gynecology Devices Panel Meeting (2
parts) |
June 23, 2003
|
| PMA
Final Decisions for May 2003 |
June 23, 2003
|
| Lab
Safety Tip #5 - Make Sure Glucose Meters Used in Testing Neonates are FDA
Cleared for Testing in Neonates |
June 20, 2003
|
| Transcript
from the 5/29/03 Circulatory System Devices Panel Meeting |
June 18, 2003
|
| Notice
of Upcoming Meeting of the General and Plastic Surgery Devices Panel -
July 24, 2003 |
June 16, 2003
|
| Summary
from the Obstetrics and Gynecology Devices Panel Meeting - June 9-10, 2003 |
June 12, 2003
|
| Fourth
Annual Report of the Medical Devices Annex to the U.S. / EC Mutual
Recognition Agreement (MRA) |
June 12, 2003
|
| Consumer
Information on Enteryx(tm) Procedure Kit |
June 10, 2003
|
| Consumer
Information on CYPHER(tm) Sirolimus-eluting Coronary Stent |
June 10, 2003
|
| On-Line
Search of Over-The Counter (OTC) Tests (Home-Use Lab Tests) |
June 10, 2003
|
| Presentation
at AdvaMed Submissions Workshop - Medical Devices: Innovation and
Regulation - June 5, 2003 |
June 10, 2003
|
| LASIK
- June 2003 Updates |
June 6, 2003
|
| 510(k)s
Final Decisions Rendered for May 2003 |
June 5, 2003
|
| Medical
Device Class 1 Recall: Portex Resuscitator |
June 4, 2003
|
| Announcement
of July 8, 2003 Public Workshop: Innovative Systems for Delivery of Drugs
and Biologics: Scientific, Clinical, and Regulatory Challenges |
June 4, 2003
|
| Actions
and Reports with a Due Date Specified by the Medical Device User Fee and
Modernization Act of 2002 or by Regulations and Notices Issued to
Implement MDUFMA (updated June 3, 2003) |
June 4, 2003
|
| Medical
Devices; Designation of Special Control for Eight Surgical Suture Devices |
June 3, 2003
|
| FDA
Patient Safety News - June Edition - Now Available |
June 2, 2003
|
|
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